Navidea Biopharmaceuticals Announces Positive Top-Line Results from Interim Analysis of Lymphoseek® Phase 3 Clinical Trial in Head and Neck Cancer

- Lymphoseek Meets Primary Endpoint in Identification of Sentinel Lymph Nodes Against Pathology Gold Standard -

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on the development and commercialization of precision diagnostic radiopharmaceuticals, today announced top-line results from the interim analysis of its Phase 3 clinical trial, NEO3-06, of Lymphoseek® (technetium 99m tilmanocept) Injection in patients with head and neck squamous cell carcinoma.

Read more: Navidea Biopharmaceuticals Inc ( NAVB )

Astex Pharmaceuticals Pipeline Data Presentations at AACR

Astex Pharmaceuticals, Inc. (ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, today announced the acceptance of thirteen abstracts covering internal and partner funded pipeline product data for poster or oral presentation at the American Association for Cancer Research (AACR) Annual Meeting April 6 to 10, 2013 in Washington, DC.

"AACR will be a foundational meeting for presenting significant data supporting our clinical programs," said James S.J. Manuso, PhD, chairman and chief executive officer. "Additional data presentations are anticipated for future meetings. Preliminary SGI-110 phase 2 data are expected to be presented at ASH."

Read more: Astex Pharmaceuticals Inc ( ASTX )

Oncolytics Biotech® Inc. Meets Primary Overall Statistical Endpoint in U.S. Phase 2 Study of REOLYSIN® in Squamous Cell Lung Cancer

Oncolytics Biotech Inc. ("Oncolytics" or the "Company") (TSX:ONC.TO - News) (NASDAQ:ONCY - News) today announced that it has met the primary overall statistical endpoint in its U.S. Phase 2 single arm clinical trial in patients with squamous cell carcinoma of the lung (SCCLC) using intravenous administration of REOLYSIN in combination with carboplatin and paclitaxel in patients with metastatic stage IIIB, or stage IV, or recurrent SCCLC who are chemotherapy naïve for their metastatic or recurrent cancer (REO 021).

The study is a two-stage design with a primary overall endpoint of objective tumor response rate. The Company saw a sufficient number of responses in the first stage of the study to proceed with enrollment in the second stage.

Read more: Oncolytics Biotech Inc ( ONC / ONCY )

Repros Reports Both Primary Endpoints Successfully Met in First Pivotal Study of Androxal(R)

  • 79-83% in normal testosterone (T) range (FDA requirement 75%)
  • No patient elevated beyond normal range
  • Androxal's impact on sperm concentration meets FDA non-inferiority threshold compared to placebo
  • Potential key points of differentiation from gels

Repros Therapeutics Inc.(R) (RPRX) today reported top-line results for the first pivotal study of Androxal, ZA-301, in the treatment of secondary hypogonadism. Results for the Intent-to-Treat population met both co-primary endpoints mandated by the FDA. The Intent-to-Treat population included all men randomized in the study whether or not they completed the study.

151 subjects were randomized into the study, 38 on placebo and 113 on Androxal.

Read more: Repros Therapeutics Inc ( RPRX )

Acura Pharmaceuticals Reaches Key Milestone With Entrance Into Chain Drug Store Market

KERR DRUG First Chain Drug Store Customer to Stock Nexafed(R) -- Next Generation Cold/Allergy Medicine With Abuse-Deterrent Technology -- Joining the Fight Against Meth Abuse

Acura Pharmaceuticals, Inc. ( NASDAQ : ACUR ) today announced that its new next generation pseudoephedrine with abuse deterrent technology will now be stocked by chain drug store KERR DRUG. Nexafed® [pseudoephedrine hydrochloride (HCl)], is a 30 mg immediate-release pseudoephedrine product that combines effective nasal-congestion relief with a unique technology that disrupts the conversion of pseudoephedrine into the dangerous drug, methamphetamine (meth). Meth production and abuse is a growing problem in communities nationwide.

Read more: Acura Pharmaceuticals Inc ( ACUR )